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Intervention Review

Statins for the primary prevention of cardiovascular disease

  1. Fiona Taylor1,*,
  2. Kirsten Ward1,
  3. Theresa HM Moore2,
  4. Margaret Burke3,
  5. George Davey Smith4,
  6. Juan P Casas1,
  7. Shah Ebrahim1

Editorial Group: Cochrane Heart Group

Published Online: 19 JAN 2011

Assessed as up-to-date: 8 SEP 2007

DOI: 10.1002/14651858.CD004816.pub4


How to Cite

Taylor F, Ward K, Moore THM, Burke M, Davey Smith G, Casas JP, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4.

Author Information

  1. 1

    London School of Hygiene and Tropical Medicine, Department of Non-communicable Disease Epidemiology, London, UK

  2. 2

    University of Bristol, Academic Unit of Psychiatry, School of Social and Community Medicine, Bristol, UK

  3. 3

    University of Bristol, Department of Social Medicine, Bristol, UK

  4. 4

    University of Bristol, School of Social and Community Medicine, Bristol, UK

*Fiona Taylor, Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Fiona.Taylor@lshtm.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 JAN 2011

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. Resumen

Background

Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of coronary heart disease (CHD) is an important goal of pharmacotherapy. Statins are the first-choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with coronary artery disease. The case for primary prevention, however, is less clear.

Objectives

To assess the effects, both harms and benefits, of statins in people with no history of CVD.

Search methods

To avoid duplication of effort, we checked reference lists of previous systematic reviews. We searched the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (2001 to March 2007) and EMBASE (2003 to March 2007). There were no language restrictions.

Selection criteria

Randomised controlled trials of statins with minimum duration of one year and follow-up of six months, in adults with no restrictions on their total low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD, were included.

Data collection and analysis

Two authors independently selected studies for inclusion and extracted data. Outcomes included all cause mortality, fatal and non-fatal CHD, CVD and stroke events, combined endpoints (fatal and non-fatal CHD, CVD and stroke events), change in blood total cholesterol concentration, revascularisation, adverse events, quality of life and costs. Relative risk (RR) was calculated for dichotomous data, and for continuous data pooled weighted mean differences (with 95% confidence intervals) were calculated.

Main results

Fourteen randomised control trials (16 trial arms; 34,272 participants) were included. Eleven trials recruited patients with specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). All-cause mortality was reduced by statins (RR 0.84, 95% CI 0.73 to 0.96) as was combined fatal and non-fatal CVD endpoints (RR 0.70, 95% CI 0.61 to 0.79). Benefits were also seen in the reduction of revascularisation rates (RR 0.66, 95% CI 0.53 to 0.83). Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no clear evidence of any significant harm caused by statin prescription or of effects on patient quality of life.

Authors' conclusions

Reductions in all-cause mortality, major vascular events and revascularisations were found with no excess of cancers or muscle pain among people without evidence of cardiovascular disease treated with statins.  Other potential adverse events were not reported and some trials included people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. Resumen

Statins for the primary prevention of cardiovascular disease

Cardiovascular disease (CVD) is ranked as the number one cause of mortality and is a major cause of morbidity world wide. Reducing high blood cholesterol which is a risk factor for CVD events is an important goal of medical treatment. Statins are the first-choice agents. Since the early statin trials were reported, several reviews of the effects of statins have been published highlighting their benefits particularly in people with a past history of CVD. However for people without a past history of CVD (primary prevention), the evidence is less clear. The aim of this systematic review is to assess the effects, both in terms of benefits and harms of statins for the primary prevention of CVD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE until 2007. We found 14 randomised control trials with 16 trial arms (34,272 patients) dating from 1994 to 2006. All were randomised control trials comparing statins with usual care or placebo. Duration of treatment was minimum one year and with follow up of a minimum of six months. All cause mortality. coronary heart disease and stroke events were reduced with the use of statins as was the need for revascularisations. Statin treatment reduced blood cholesterol. Taking statins did not increase the risk of adverse effects such as cancer. and few trials reported on costs or quality of life. This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

 

Resumen

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. Resumen

Antecedentes

Estatinas para la prevención primaria de las enfermedades cardiovasculares

La reducción del colesterol sanguíneo elevado, un factor de riesgo de enfermedad cardiovascular (EC) en personas con y sin antecedentes de cardiopatía coronaria es un objetivo importante de la farmacoterapia. Las estatinas son los agentes de primera elección. En revisiones anteriores de los efectos de las estatinas, se han destacado sus beneficios en pacientes con coronariopatía. Sin embargo, estos efectos beneficiosos son menos claros para la prevención primaria.

Objetivos

Evaluar los efectos beneficiosos y perjudiciales de las estatinas en personas sin antecedentes de EC.

Estrategia de búsqueda

Para evitar la duplicación de esfuerzos, se comprobaron las listas de referencias de revisiones sistemáticas anteriores. Se realizaron búsquedas en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials, CENTRAL), (número 1, 2007), MEDLINE (2001 hasta marzo 2007) y en EMBASE (2003 hasta marzo 2007). No hubo restricciones de idioma.

Criterios de selección

Se incluyeron ensayos controlados con asignación aleatoria de estatinas con una duración mínima de un año y seguimiento de seis meses, en adultos sin restricciones en el nivel total de colesterol de lipoproteína de baja densidad (LDL, por sus siglas en inglés, low density lipoprotein) o de lipoproteína de alta densidad (HDL, por sus siglas en inglés, high density lipoprotein) y en que el 10% o menos tenían antecedentes de EC.

Obtención y análisis de los datos

Dos autores seleccionaron los estudios de forma independiente para la inclusión y extrajeron los datos. Los resultados incluyeron: la mortalidad por todas las causas, la cardiopatía coronaria mortal y no mortal, los eventos de accidente cerebrovascular y EC, las variables principales de evaluación combinadas (cardiopatía coronaria mortal y no mortal, eventos de accidente cerebrovascular y EC), el cambio en la concentración de colesterol total sanguíneo, la revascularización, los eventos adversos, la calidad de vida y el costo. Se calculó el riesgo relativo (RR) de los datos dicotómicos y la diferencia de medias ponderadas agrupadas de los datos continuos (con intervalos de confianza del 95%).

Resultados principales

Se incluyeron 14 ensayos controlados con asignación aleatoria (16 brazos de ensayo; 34 272 participantes). Once ensayos reclutaron a pacientes con trastornos específicos (lípidos elevados, diabetes, hipertensión, microalbuminuria). La mortalidad por todas las causas fue reducida por las estatinas (RR 0,83; IC del 95%: 0,73 a 0,95) como también las variables principales de evaluación de EC mortal y no mortal combinadas (RR 0,70; IC del 95%: 0,61 a 0,79). También se notaron beneficios en la reducción de las tasas de revascularización (RR 0,66; IC del 95%: 0,53 a 0,83). Se redujo el colesterol total y el colesterol LDL en todos los ensayos, pero hubo pruebas de heterogeneidad de los efectos. No hubo pruebas claras de efectos perjudiciales significativos causados por la prescripción de las estatinas o de efectos sobre la calidad de vida del paciente.

Conclusiones de los autores

Se encontraron reducciones en la mortalidad por todas las causas, los eventos vasculares graves y las revascularizaciones sin exceso de casos de cáncer o de dolor muscular entre los pacientes sin pruebas de enfermedad cardiovascular tratadas con estatinas. No se informaron otros eventos adversos potenciales y algunos ensayos incluyeron a pacientes con enfermedades cardiovasculares. Sólo hubo pruebas limitadas que indicaron que la prevención primaria con estatinas puede ser eficaz en función de los costes y mejorar la calidad de vida del paciente. Se debe tener cuidado al prescribir estatinas para la prevención primaria a personas con riesgo cardiovascular bajo.

Traducción

Traducción realizada por el Centro Cochrane Iberoamericano